by
Tuula Rintala
Director, Quality of Care and Advocacy
EBMT, European Society for Blood and Marrow Transplantation
Barcelona, Spain
The FACT (Foundation for the Accreditation of Cellular Therapy) and JACIE (Joint Accreditation Committee ISCT-Europe & EBMT) have been working over the last year on revising the 9th edition of Haematopoietic Stem Cell Transplantation and the 3rd edition of Immune Effector Cell (IEC) Standards. These standards serve as the foundation for accreditation, guiding Stem Cell Transplantation and Cellular Therapy facilities and laboratories worldwide in maintaining compliance with evolving medical, scientific, and regulatory advancements. The Standards are revised, every three years, to account for changes in the scientific landscape, clinical practices, and regulatory requirements. The review process is conducted by sub-committees for clinical, collection processing, quality management and immune effector cells (IECs) with experts from both FACT and JACIE communities. These committees evaluate existing standards, identify gaps, and propose new or revised standards based on emerging trends and evidence-based practices.
The objective of the FACT-JACIE HCT Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and other cellular therapies. The scope of the Standards includes but is not limited to hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use, immune effector cells (IECs), and genetically modified cells.
A key feature of the FACT-JACIE development process is public consultation. Draft standards are made available for comment by the global cellular therapy community, including healthcare professionals, regulatory agencies, and the general public. This transparent approach allows for broader input, ensuring that the standards are reflective of real-world clinical environments. Feedback from public consultation is carefully reviewed by the committees, and necessary adjustments are made to the draft prior to approval by the both organisations.
Join in the Public Consultation Process
In order to join in the public consultation process, please download a copy of the draft HCT and IEC Standards at: https://www.factglobal.org/standards/public-comments/
There are two surveys. Complete the HCT survey, if your comments are related to HCT and/or IEC practice. Complete the IEC survey if your comments are related to IEC only practice. Additional instructions can be found in the surveys at https://redcap.factglobal.org/surveys/?s=JFK339PTPYEKHYLF
The review for both the HCT and IEC Standards includes multiple structural and content changes for which we are requesting specific comments. These include:
- Standards and edits introduced to standardize practices related to Risk Evaluation and Mitigation Strategies (REMS).
- New Standards recommending a Chain of Identity Identifier (C7.1.3, C7.3.2, C7.3.5, D7.1.3, and D7.3.2) to be assigned before or at the time of collection to each collection intended for further manufacturing.
- The Standard for Processing Facility Director qualifications (Standard D3.1.1) has not changed. The committee proposed guidance to consider a pathway for people who do not possess a doctoral level degree to serve as the director.
- New audit requirements were added in Clinical, Collection, and Processing Standards 4.8.4 through 4.8.6.
There is no limit to the number of comments you can submit. This survey allows you to enter up to thirty (30) comments per section. If you wish to provide additional comments, please start a new survey. You can submit comments until 15th December 2024.
The published draft includes a redlined document intended to highlight the changes made to these Standards. Minor changes to the organization or phrasing (including edits to correct or improve grammar and punctuation) of the document may not be tracked. Some of the highlighted changes are new standards; others are intended to clarify rather than change the intent of existing standards. In addition, many changes were made to harmonize the language and provide greater consistency among all sets of FACT Standards.
For questions regarding the survey, please contact Monique Summers-Currington, FACT Standards Development Manager at Monique.Summers@factglobal.org.
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